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Takeda’s EXKIVITY™ (mobocertinib) Approved by U.S. FDA as the First Oral Therapy Specifically Designed for Patients with EGFR Exon20 Insertion+ NSCLC

Takeda’s EXKIVITY™ (mobocertinib) Approved by U.S. FDA as the First Oral Therapy Specifically Designed for Patients with EGFR Exon20 Insertion+ NSCLC

− Approval based on Phase 1/2 trial results, which demonstrated clinically meaningful responses with a median duration of response (DoR) of approximately 1.5 years

− Next-generation sequencing (NGS) companion diagnostic test approved simultaneously to support identification of patients with EGFR Exon20 insertion mutations

OSAKA, Japan & CAMBRIDGE, Mass.–(BUSINESS WIRE)–
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) has approved EXKIVITY (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. EXKIVITY, which was granted priority review and received Breakthrough Therapy Designation, Fast Track Designation and Orphan Drug Designation from the FDA, is the first and only approved oral therapy specifically designed to target EGFR Exon20 insertion mutations. This indication is approved under Accelerated Approval based on overall response rate (ORR) and DoR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

“The approval of EXKIVITY introduces a new and effective treatment option for patients with EGFR Exon20 insertion+ NSCLC, fulfilling an urgent need for this difficult-to-treat cancer,” said Teresa Bitetti, president, Global Oncology Business Unit, Takeda. “EXKIVITY is the first and only oral therapy specifically designed to target EGFR Exon20 insertions, and we are particularly encouraged by the duration of the responses observed with a median of approximately 1.5 years. This approval milestone reinforces our commitment to meeting the needs of underserved patient populations within the oncology community.”

The FDA simultaneously approved Thermo Fisher Scientific’s Oncomine Dx Target Test as an NGS companion diagnostic for EXKIVITY to identify NSCLC patients with EGFR Exon20 insertions. NGS testing is critical for these patients, as it can enable more accurate diagnoses compared to polymerase chain reaction (PCR) testing, which detects less than 50% of EGFR Exon20 insertions.

“EGFR Exon20 insertion+ NSCLC is an underserved cancer that we have been unable to target effectively with traditional EGFR TKIs,” said Pasi A. Jänne, MD, PhD, Dana Farber Cancer Institute. “The approval of EXKIVITY (mobocertinib) marks another important step forward that provides physicians and their patients with a new targeted oral therapy specifically designed for this patient population that has shown clinically meaningful and sustained responses.”

“Patients with EGFR Exon20 insertion+ NSCLC have historically faced a unique set of challenges living with a very rare lung cancer that is not only underdiagnosed, but also lacking targeted treatment options that can improve response rates,” said Marcia Horn, executive director, Exon 20 Group at ICAN, International Cancer Advocacy Network. “As a patient advocate working with EGFR Exon20 insertion+ NSCLC patients and their families every day for nearly five years, I am thrilled to witness continued progress in the fight against this devastating disease and am grateful for the patients, families, healthcare professionals and scientists across the globe who contributed to the approval of this promising targeted therapy.”

The FDA approval is based on results from the platinum-pretreated population in the Phase 1/2 trial of EXKIVITY, which consisted of 114 patients with EGFR Exon20 insertion+ NSCLC who received prior platinum-based therapy and were treated at the 160 mg dose. Results were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting from the Phase 1/2 trial and demonstrated a confirmed ORR of 28% per independent review committee (IRC) (35% per investigator) as well as a median DoR of 17.5 months per IRC, a median overall survival (OS) of 24 months and a median progression-free survival (PFS) of 7.3 months per IRC.

The most common adverse reactions (>20%) were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain. The EXKIVITY Prescribing Information includes a boxed warning for QTc prolongation and Torsades de Pointes, and warnings and precautions for interstitial lung disease/pneumonitis, cardiac toxicity, and diarrhea.

The FDA review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), which provides a framework for concurrent submission and review of oncology products among international partners. We look forward to continuing our work with regulatory agencies across the globe to bring mobocertinib to patients.

Delivering Takeda’s Wave 1 Pipeline

Takeda is positioned to deliver near-term growth through global brand expansions and its Wave 1 pipeline, which includes multiple best-in-class/first-in-class new molecular entities (NMEs) with potential for approvals through FY2024. Our Wave 2 pipeline contains approximately 30 NMEs and next-generation platforms that will support Takeda’s sustainable growth through FY25 and beyond.

About EXKIVITY (mobocertinib)

EXKIVITYis a first-in-class, oral tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations.

EXKIVITY is approved in the U.S. for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

Results from the Phase 1/2 trial of mobocertinib have also been accepted for review by the Center for Drug Evaluation (CDE) in China for locally advanced or metastatic NSCLC patients with EGFR Exon20 insertion mutations who have been previously treated with at least one prior systemic chemotherapy.

For more information about EXKIVITY, visit www.EXKIVITY.com. For the Prescribing Information, including the Boxed Warning, please visit https://takeda.info/Exkivity-Prescribing-Information.

About EGFR Exon20 Insertion+ NSCLC

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 85% of the estimated 2.2 million new cases of lung cancer diagnosed each year worldwide, according to the World Health Organization.1,2 Patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ NSCLC make up approximately 1-2% of patients with NSCLC, and the disease is more common in Asian populations compared to Western populations.3-7 This disease carries a worse prognosis than other EGFR mutations, as EGFR TKIs – which do not specifically target EGFR Exon20 insertions – and chemotherapy provide limited benefit for these patients.

Takeda is committed to continuing research and development to meet the needs of the lung cancer community through the discovery and delivery of transformative medicines.

EXKIVITY IMPORTANT SAFETY INFORMATION

QTc Interval Prolongation and Torsades de Pointes: EXKIVITY can cause life-threatening heart rate-corrected QT (QTc) prolongation, including Torsades de Pointes, which can be fatal, and requires monitoring of QTc and electrolytes at baseline and periodically during treatment. Increase monitoring frequency in patients with risk factors for QTc prolongation. Avoid use of concomitant drugs which are known to prolong the QTc interval and use of strong or moderate CYP3A inhibitors with EXKIVITY, which may further prolong the QTc. Withhold, reduce the dose, or permanently discontinue EXKIVITY based on the severity of QTc prolongation.

Interstitial Lung Disease (ILD)/Pneumonitis: Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Immediately withhold EXKIVITY in patients with suspected ILD/pneumonitis and permanently discontinue EXKIVITY if ILD/pneumonitis is confirmed.

Cardiac Toxicity: Monitor cardiac function, including left ventricular ejection fraction, at baseline and during treatment. Withhold, resume at reduced dose or permanently discontinue based on severity.

Diarrhea: Diarrhea may lead to dehydration or electrolyte imbalance, with or without renal impairment. Monitor electrolytes and advise patients to start an antidiarrheal agent at first episode of diarrhea and to increase fluid and electrolyte intake. Withhold, reduce the dose, or permanently discontinue EXKIVITY based on the severity.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective non-hormonal contraception.

Takeda’s Commitment to Oncology

Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit www.takedaoncology.com.

About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries. For more information, visit https://www.takeda.com.

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Medical information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

1 Sung H. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. https://pubmed.ncbi.nlm.nih.gov/33538338/. Accessed May 27, 2021

2 American Cancer Society. What is Non-Small Cell Lung Cancer? https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html.

3 Riess, Jonathan W. Diverse EGFR Exon 20 Insertions and Co-Occurring Molecular Alterations Identified by Comprehensive Genomic Profiling of NSCLC. https://www.jto.org/article/S1556-0864(18)30770-6/fulltext. Accessed April 7, 2020.

4 Fang, Wenfeng. BMC Cancer. EGFR exon 20 insertion mutations and response to osimertinib in non-small-cell lung cancer. https://bmccancer.biomedcentral.com/articles/10.1186/s12885-019-5820-0. Accessed April 7, 2020.

5 Kobayashi Y, Mitsudomi T. Not all epidermal growth factor receptor mutations in lung cancer are created equal: Perspectives for individualized treatment strategy. Cancer Sci. 2016;107(9):1179-1186. doi:10.1111/cas.12996

6 Yatabe Y, Kerr KM, Utomo A, et al. EGFR mutation testing practices within the Asia Pacific region: results of a multicenter diagnostic survey. J Thorac Oncol. 2015;10(3):438-445. doi:10.1097/JTO.0000000000000422

7 Kris MG, Johnson BE, Berry LD, et al. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. JAMA. 2014;311(19):1998-2006. doi:10.1001/jama.2014.3741

Japanese Media

Ryoko Matsumoto

[email protected]

+81 (0) 3-3278-3414

Media Outside Japan

Lauren Padovan

[email protected]
+1 (617) 444-1419

KEYWORDS: Massachusetts United States Japan North America Asia Pacific

INDUSTRY KEYWORDS: Science Biotechnology Research Pharmaceutical Oncology Health FDA Clinical Trials

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Voya Global Advantage and Premium Opportunity Fund & Voya Infrastructure, Industrials and Materials Fund Declare Quarterly Distributions

Voya Global Advantage and Premium Opportunity Fund & Voya Infrastructure, Industrials and Materials Fund Declare Quarterly Distributions

SCOTTSDALE, Ariz.–(BUSINESS WIRE)–
Voya Investment Management, the asset management business of Voya Financial, Inc. (NYSE: VOYA), announces the quarterly distribution on the common shares of two of its closed-end funds: Voya Global Advantage and Premium Opportunity Fund (NYSE: IGA) and Voya Infrastructure, Industrials and Materials Fund (NYSE: IDE) (each a “Fund” and together the “Funds”).

With respect to the Funds, the distribution will be paid on October 15, 2021, to shareholders of record on October 4, 2021. The ex-dividend date is October 1, 2021. The distribution per share for each Fund is as follows:

 

 

Fund

Distribution Per Share

Voya Global Advantage and Premium Opportunity Fund

$0.197

Voya Infrastructure, Industrials and Materials Fund

$0.229

The Funds intend to make regular quarterly distributions based on the past and projected performance of each Fund. The amount of quarterly distributions may vary, depending on a number of factors. As portfolio and market conditions change, the rate of distributions on the common shares may change. There can be no assurance that the Funds will be able to declare a distribution in each period. Past performance is no guarantee of future results.

The following information is required under each Fund’s managed distribution policy and sets forth an estimate of the sources of each Fund’s distribution paid July 15, 2021 and distributions paid fiscal year-to-date. Amounts are expressed on a per common share basis and as a percentage of the distribution amount.

Voya Global Advantage and Premium Opportunity Fund

Source

July

Distribution

% of July

Distribution

Cumulative

Distributions paid

Fiscal Year-to-Date

% of the Cumulative

Distributions for the

Fiscal Year-to-Date1

Net Investment Income

$ 0.054

 

27.49%

 

$ 0.112

 

28.54%

Net Realized Short-Term Capital Gains

$ 0.000

 

0.00%

 

$ 0.000

 

0.00%

Net Realized Long-Term Capital Gains

$ 0.000

 

0.00%

 

$ 0.000

 

0.00%

Return of Capital or Other Capital Source(s)

$ 0.143

 

72.51%

 

$ 0.282

 

71.46%

Total per common share

$ 0.197

 

100.00%

 

$ 0.394

 

100.00%

Voya Infrastructure, Industrials and Materials Fund

Source

July

Distribution

% of July

Distribution

Cumulative

Distributions paid

Fiscal Year-to-Date

% of the Cumulative

Distributions paid

Fiscal Year-to-Date1

Net Investment Income

$ 0.066

 

29.01%

 

$ 0.152

 

33.22%

Net Realized Short-Term Capital Gains

$ 0.000

 

0.00%

 

$ 0.000

 

0.00%

Net Realized Long-Term Capital Gains

$ 0.000

 

0.00%

 

$ 0.000

 

0.00%

Return of Capital or Other Capital Source(s)

$ 0.163

 

70.99%

 

$ 0.306

 

66.78%

Total per Common Share

$ 0.229

 

100.00%

 

$ 0.458

 

100.00%

1 The Fund’s fiscal year is March 1, 2021 to February 28, 2022.

IMPORTANT DISCLOSURE: You should not draw any conclusions about each Fund’s investment performance from the amount of each distribution or from the terms of the Funds’ Plan. Each Fund estimates that it has distributed more than its income and net realized capital gains; therefore, a portion of your distribution may be a return of capital. A return of capital may occur, for example, when some or all of the money that you invested in the Funds is paid back to you. A return of capital distribution does not necessarily reflect each Fund’s investment performance and should not be confused with ‘yield’ or ‘income.’ The amounts and sources of distributions reported in this Section 19(a) Notice are only estimates and are not being provided for tax reporting purposes. The actual amounts and sources of the amounts for tax reporting purposes will depend upon each Fund’s investment experience during the remainder of its fiscal year and may be subject to changes based on tax regulations. Each Fund will send you a Form 1099-DIV for the calendar year that will tell you how to report these distributions for federal income tax purposes.

Set forth in the tables below is information relating to each Fund’s performance based on its net asset value (NAV) for certain periods.

Voya Global Advantage and Premium Opportunity Fund

Average annual total return at NAV for the five year period ended on June 30, 20211

8.51%

Annualized current distribution rate expressed as a percentage of NAV as of June 30, 20212

7.37%

Cumulative total return at NAV for the fiscal year through June 30, 20213

10.32%

Cumulative fiscal year to date distribution rate as a percentage of NAV as of June 30, 20214

1.84%

Voya Infrastructure, Industrials and Materials Fund

Average annual total return at NAV for the five year period ended on June 30, 20211

8.47%

Annualized current distribution rate expressed as a percentage of NAV as of June 30, 20212

6.95%

Cumulative total return at NAV for the fiscal year through June 30, 20213

9.30%

Cumulative fiscal year-to-date distribution rate as a percentage of NAV as of June 30, 20214

1.74%

1

 

Average annual total return at NAV represents the compound average of the annual NAV total returns of the Fund for the five year period ended on June 30, 2021.

2

 

The annualized current distribution rate is the cumulative distribution rate annualized as a percentage of the Fund’s NAV as of June 30, 2021.

3

 

Cumulative total return at NAV is the percentage change in the Fund’s NAV for the period from the beginning of its fiscal year to June 30, 2021 including distributions paid and assuming reinvestment of those distributions.

4

 

Cumulative fiscal year distribution rate for the period from the year-to-date period as a percentage of the Fund’s NAV as of June 30, 2021.

Past performance is no guarantee of future results. The performance quoted represents past performance. Investment return and principal value of an investment will fluctuate, and shares, when redeemed, may be worth more or less than their original cost. Current performance may be lower or higher than the performance data quoted.

Shares of closed-end funds often trade at a discount from their net asset value. The market price of Fund shares may vary from net asset value based on factors affecting the supply and demand for shares, such as Fund distribution rates relative to similar investments, investors’ expectations for future distribution changes, the clarity of the Fund’s investment strategy and future return expectations, and investors’ confidence in the underlying markets in which the Fund invests. Fund shares are subject to investment risk, including possible loss of principal invested. No Fund is a complete investment program and you may lose money investing in a Fund. An investment in a Fund may not be appropriate for all investors. Before investing, prospective investors should consider carefully the Fund’s investment objective, risks, charges and expenses.

Certain statements made on behalf of the Fund in this release are forward-looking statements. The Fund’s actual future results may differ significantly from those anticipated in any forward-looking statements due to numerous factors, including but not limited to a decline in value in equity markets in general or the Fund’s investments specifically. Neither the Fund nor Voya Investment Management undertake any responsibility to update publicly or revise any forward-looking statement.

This information should not be used as a basis for legal and/or tax advice. In any specific case, the parties involved should seek the guidance and advice of their own legal and tax counsel.

About Voya® Investment Management

A leading, active asset management firm, Voya Investment Management manages, as of June 30, 2021, over $253 billion for affiliated and external institutions as well as individual investors. With more than 40 years of history in asset management, Voya Investment Management has the experience and resources to provide clients with investment solutions with an emphasis on equities, fixed income, and multi-asset strategies and solutions. Voya Investment Management was named in 2015, 2016, 2017, 2018, 2019 and 2020 as a “Best Places to Work” by Pensions and Investments magazine. For more information, visit voyainvestments.com. Follow Voya Investment Management on Twitter @VoyaInvestments.

SHAREHOLDER INQUIRIES: Shareholder Services at (800) 992-0180; voyainvestments.com

CONTACT: Kris Kagel, (800) 992-0180

KEYWORDS: Arizona United States North America

INDUSTRY KEYWORDS: Banking Other Professional Services Professional Services Finance

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News Corp to Participate in Goldman Sachs 30th Annual Communacopia Conference

News Corp to Participate in Goldman Sachs 30th Annual Communacopia Conference

NEW YORK–(BUSINESS WIRE)–
News Corp announced today that Chief Executive Robert Thomson will participate in the Goldman Sachs 30th Annual Communacopia Conference on Wednesday, September 22, 2021. The session will begin at 3:45pm EDT.

To listen to a live webcast, please visit the News Corp website at https://investors.newscorp.com/calendar-events. A replay of the webcast is expected to be available at the same location for a period of time following the conference.

About News Corp

News Corp (Nasdaq: NWS, NWSA; ASX: NWS, NWSLV) is a global, diversified media and information services company focused on creating and distributing authoritative and engaging content and other products and services. The company comprises businesses across a range of media, including: digital real estate services, subscription video services in Australia, news and information services and book publishing. Headquartered in New York, News Corp operates primarily in the United States, Australia, and the United Kingdom, and its content and other products and services are distributed and consumed worldwide. More information is available at: http://www.newscorp.com.

News Corp Investor Relations

Michael Florin

212-416-3363

[email protected]

News Corp Corporate Communications

Jim Kennedy

212-416-4064

[email protected]

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Advertising Entertainment Communications Other Entertainment TV and Radio Publishing Public Relations/Investor Relations

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Garage Gurus® Announces Sponsorship of the First U.S. Auto Tech National Championship

Both Professional and Student Auto Technicians Are Invited to Participate; Competition Tests the Skills Necessary to Become a Top Auto Tech

PR Newswire

SOUTHFIELD, Mich., Sept. 15, 2021 /PRNewswire/ — Garage Gurus®, an industry-leading training and support platform from Tenneco Inc.’s (NYSE: TEN) DRiV group, announces its latest support for up-and-coming technicians with its sponsorship of the first U.S. Auto Tech National Championship. A part of the larger Elite Trades Series, the U.S. Auto Tech National Championship will set out to find the top technicians in the country and have them face off against one another for a chance to win over $200,000 in cash and prizes.

The Garage Gurus-sponsored U.S. Auto Tech National Championship will include in-person qualifying events across six markets in the United States, to be held at Garage Gurus training locations and other partner retail locations, trade schools and high-profile consumer event locations. At these qualifying events, professional and student technicians will compete in a timed, chassis-based challenge to test their repair skills. Each competitor will be scored and judged on overall time, workmanship, and safety by Garage Gurus’ ASE-certified repair professionals and representatives from the University of Northwestern Ohio. The top 32 professionals and top 32 students competing in these qualifying events will advance to the National Championship, to be held in Nashville, Tenn., on December 13-14, 2021. Cash awards will be given to the top three finishers in both the professional and student technician categories: $40,000 each for first place winners; $20,000 each for second place winners; and $10,000 each for third place winners.   

Qualifying locations for each competition are:

  • Qualifying Tour Event #1 – Lima, Ohio
  • Qualifying Tour Event #2 – Chicago, Ill.
  • Qualifying Tour Event #3 – Detroit, Mich.
  • Qualifying Tour Event #4 – Boston, Mass.
  • Qualifying Tour Event #5 – Atlanta, Ga.
  • Qualifying Tour Event #6 – Springville, Utah

“Garage Gurus has long been both a creator and an ardent supporter of training initiatives and scholarship programs to help technicians improve their skills and develop their careers,” said Rebecca Mahan, Executive Director, Americas Brand Marketing & Channel Engagement, DRiV.  “We are excited to sponsor this competition and help out both existing technicians sharpen their skills, as well as encourage future technicians to continue developing their skills for long-term careers in the automotive aftermarket industry.”

To learn more about the U.S. Auto Tech National Championships, head to www.usatnc.com for more information. To register for the U.S. Auto Tech National Championship competition at a location near you, click here. 

Launched in 2015, Garage Gurus is a first-of-its-kind national training platform designed to help front-line automotive service professionals keep pace with the latest vehicle technologies by offering onsite, online and on-demand instruction. State-of-the-art Garage Gurus technical education centers operate in 11 U.S. markets – Atlanta; Baltimore; Boston; Chicago; Dallas/Fort Worth; New Hyde Park, N.Y.; Rancho Dominguez, Calif.; South Florida; St. Louis; suburban Detroit; and Van Nuys, Calif. Garage Gurus similarly will visit repair facilities and educate techs on the latest repair tools, replacement part solutions and technology using its fleet of product technology vans. 

To learn more about Garage Gurus, visit www.garagegurus.tech.

About Tenneco

Tenneco is one of the world’s leading designers, manufacturers and marketers of automotive products for original equipment and aftermarket customers, with full year 2020 revenues of $15.4 billion and approximately 73,000 team members working at more than 270 sites worldwide.  Through our four business groups, Motorparts, Performance Solutions, Clean Air and Powertrain, Tenneco is driving advancements in global mobility by delivering technology solutions for diversified global markets, including light vehicle, commercial truck, off-highway, industrial, motorsport and the aftermarket.

CONTACT:                           

Karen Shulhan (DRiV) – 248.354.4383
[email protected]

Bill Dawson (DRiV) – 847.482.5807
[email protected]

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/garage-gurus-announces-sponsorship-of-the-first-us-auto-tech-national-championship-301378064.html

SOURCE DRiV

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Neuberger Berman Closed-End Municipal Funds Announce Monthly Distributions

PR Newswire

NEW YORK, Sept. 15, 2021 /PRNewswire/ — The Board of each of Neuberger Berman Municipal Fund Inc. (NYSE American: NBH), Neuberger Berman California Municipal Fund Inc. (NYSE American: NBW), and Neuberger Berman New York Municipal Fund Inc. (NYSE American: NBO) has declared monthly distributions for the dates below. The Funds seek to provide income that is exempt from regular federal income tax. Additionally, Neuberger Berman California Municipal Fund Inc. seeks to provide income that is exempt from California personal income tax and Neuberger Berman New York Municipal Fund Inc. seeks to provide income that is exempt from New York State and New York City personal income tax. Distributions of the Funds may be subject to the federal alternative minimum tax for some stockholders. Each Fund’s distribution announced today is payable on October 15, 2021, has a record date of September 30, 2021 and an ex-date of September 29, 2021.

The Funds will make the distributions described above in the following per share amounts:

NBH

Neuberger Berman Municipal Fund Inc.

$0.06244

NBW

Neuberger Berman California Municipal Fund Inc.

$0.04480

NBO

Neuberger Berman New York Municipal Fund Inc.

$0.03933

In compliance with Section 19 of the Investment Company Act of 1940, as amended, a notice would be provided for any distribution that does not consist solely of net investment income. The notice would be for informational purposes and not for tax reporting purposes, and would disclose, among other things, estimated portions of the distribution, if any, consisting of net investment income, capital gains and return of capital. The final determination of the source and tax characteristics of all distributions paid in 2021 will be made after the end of the year.

About Neuberger Berman

Neuberger Berman, founded in 1939, is a private, independent, employee-owned investment manager. The firm manages a range of strategies—including equity, fixed income, quantitative and multi-asset class, private equity, real estate and hedge funds—on behalf of institutions, advisors and individual investors globally. With offices in 25 countries, Neuberger Berman’s diverse team has over 2,300 professionals. For seven consecutive years, the company has been named first or second in Pensions & Investments Best Places to Work in Money Management survey (among those with 1,000 employees or more). In 2020, the PRI named Neuberger Berman a Leader, a designation awarded to fewer than 1% of investment firms for excellence in Environmental, Social and Governance (ESG) practices. The PRI also awarded Neuberger Berman an A+ in every eligible category for our approach to ESG integration across asset classes. The firm manages $433 billion in client assets as of June 30, 2021. For more information, please visit our website at www.nb.com. 

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Statements made in this release that look forward in time involve risks and uncertainties. Such risks and uncertainties include, without limitation, the adverse effect from a decline in the securities markets or a decline in the Fund’s performance, a general downturn in the economy, competition from other closed end investment companies, changes in government policy or regulation, inability of the Fund’s investment adviser to attract or retain key employees, inability of the Fund to implement its investment strategy, inability of the Fund to manage rapid expansion and unforeseen costs and other effects related to legal proceedings or investigations of governmental and self-regulatory organizations.

Contact:

Neuberger Berman Investment Advisers LLC
Investor Information
(877) 461-1899

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SOURCE Neuberger Berman

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Timken Provides Update on 2021 Performance

PR Newswire

NORTH CANTON, Ohio, Sept. 15, 2021 /PRNewswire/ — The Timken Company (NYSE: TKR; www.timken.com), a global industrial leader in engineered bearings and power transmission products, today announced that it expects lower sales and earnings in the second half of 2021, compared to the company’s prior expectations. Timken’s results are being impacted by unabating customer and supply chain disruptions and related manufacturing inefficiencies, as well as continued inflationary pressures across the enterprise.

Underlying customer demand and end-market momentum remain strong across most sectors, and the company expects a robust industrial market environment for the remainder of 2021 and throughout 2022. Timken is working to mitigate the impact of the supply chain challenges and inflationary pressures through improved operational efficiencies and pricing. The company continues to implement price increases and expects significant price realization in 2022.

Given the unpredictability of the current environment, Timken is withdrawing its full year 2021 financial outlook, which was last updated on August 2, 2021. The company will provide further updates when it reports financial results for the third quarter of 2021.


About The Timken Company

The Timken Company (NYSE: TKR; www.timken.com) designs a growing portfolio of engineered bearings and power transmission products. With more than a century of knowledge and innovation, we continuously improve the reliability and efficiency of global machinery and equipment to move the world forward. Timken posted $3.5 billion in sales in 2020 and employs more than 17,000 people globally, operating from 42 countries. Timken is recognized among America’s Most Responsible Companies by Newsweek, the World’s Most Ethical Companies® by Ethisphere and America’s Best Employers, America’s Best Employers for New Graduates and America’s Best Employers for Women by Forbes.

Certain statements in this release (including statements regarding the company’s forecasts, estimates, plans and expectations) that are not historical in nature are “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995. In particular, the statements related to expectations regarding the company’s future financial performance are forward-looking.

The company cautions that actual results may differ materially from those projected or implied in forward-looking statements due to a variety of important factors, including: the finalization of the company’s financial statements for the third quarter of 2021; the company’s ability to respond to the changes in its end markets that could affect demand for the company’s products or services; unanticipated changes in business relationships with customers or their purchases from the company; changes in the financial health of the company’s customers, which may have an impact on the company’s revenues, earnings and impairment charges; fluctuations in material and energy costs; logistical issues associated with port closures or congestion, delays or increased costs; the impact of changes to the company’s accounting methods; political risks associated with government instability; recent world events that have increased the risks posed by international trade disputes, tariffs and sanctions; weakness in global or regional economic conditions and capital markets; the company’s ability to satisfy its obligations under its debt agreements and renew or refinance borrowings on favorable terms; fluctuations in currency valuations; changes in the expected costs associated with product warranty claims; the ability to achieve satisfactory operating results in the integration of acquired companies, including realizing any accretion, synergies, and expected cashflow generation within expected timeframes or at all; the impact on operations of general economic conditions; fluctuations in customer demand; the impact on the company’s pension obligations and assets due to changes in interest rates, investment performance and other tactics designed to reduce risk; the introduction of new disruptive technologies; unplanned plant shutdowns; the effects of government-imposed restrictions meant to address climate change; unanticipated litigation, claims, investigations or assessments; the company’s ability to maintain positive relations with unions and works councils; negative impacts to the company’s business, results of operations, financial position or liquidity as a result of COVID-19 or other epidemics and associated governmental measures such as restrictions on travel and manufacturing operations; and the company’s ability to complete and achieve the benefits of announced plans, programs, initiatives, acquisitions and capital investments. Additional factors are discussed in the company’s filings with the Securities and Exchange Commission, including the company’s Annual Report on Form 10-K for the year ended Dec. 31, 2020, quarterly reports on Form 10-Q and current reports on Form 8-K. Except as required by the federal securities laws, the company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Media Relations:

Scott Schroeder

234.262.6420
[email protected]

Investor Relations:

Neil Frohnapple

234.262.2310
[email protected]

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SOURCE The Timken Company

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Federal Realty Investment Trust To Present at BofA Securities 2021 Global Real Estate Conference

PR Newswire

N. BETHESDA, Md., Sept. 15, 2021 /PRNewswire/ — Federal Realty Investment Trust (NYSE:FRT) announced today that the Company will present at the BofA Securities 2021 Global Real Estate Conference on Tuesday, September 21, 2021 at 9:00 AM ET.

Event: Federal Realty Investment Trust Presentation at the BofA Securities 2021 Global Real Estate Conference

When: 9:00 AM ET, Tuesday, September 21, 2021

Live Webcast: FRT BofA Securities 2021 Global Real Estate Conference Presentation or under the Investors tab at www.federalrealty.com  

A replay of the webcast will be available within 24 hours after the conclusion of the live event on Federal Realty’s website at www.federalrealty.com through December 22, 2021.

About Federal Realty

Federal Realty is a recognized leader in the ownership, operation and redevelopment of high-quality retail-based properties located primarily in major coastal markets from Washington, D.C. to Boston as well as San Francisco and Los Angeles. Founded in 1962, Federal Realty’s mission is to deliver long-term, sustainable growth through investing in communities where retail demand exceeds supply. Its expertise includes creating urban, mixed-use neighborhoods like Santana Row in San Jose, California, Pike & Rose in North Bethesda, Maryland and Assembly Row in Somerville, Massachusetts. These unique and vibrant environments that combine shopping, dining, living and working provide a destination experience valued by their respective communities. Federal Realty’s 105 properties include approximately 3,000 tenants, in 25 million square feet, and approximately 2,900 residential units. 

Federal Realty has increased its quarterly dividends to its shareholders for 54 consecutive years, the longest record in the REIT industry. Federal Realty is an S&P 500 index member and its shares are traded on the NYSE under the symbol FRT. For additional information about Federal Realty and its properties, visit www.federalrealty.com.

Investor Inquiries:

Leah Andress Brady

Director, Investor Relations

301.998.8265


[email protected] 

Media Inquiries:

Brenda Pomar

Director, Corporate Communications

301.998.8316


[email protected] 

 

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SOURCE Federal Realty Investment Trust

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Veritex Holdings, Inc. Announces Increase and Extension to Its Stock Buyback Program

DALLAS, Sept. 15, 2021 (GLOBE NEWSWIRE) — The Board of Directors (the “Board”) of Veritex Holdings, Inc. (Nasdaq: VBTX) (the “Company”) authorized an increase and extension of its stock buyback program (the “Stock Buyback Program”) pursuant to which the Company may, from time to time, purchase shares of its outstanding common stock. The Stock Buyback Program authorized the Company to purchase up to $175.0 million of its outstanding common stock and that amount has been increased by the Board to $250.0 million. The Board also authorized an extension of the expiration date of the Stock Buyback Program from December 31, 2021 to December 31, 2022. The shares may be repurchased in the open market or in privately negotiated transactions from time to time, depending upon market conditions and other factors, and in accordance with applicable regulations of the Securities and Exchange Commission (the “SEC”). The Stock Buyback Program does not obligate the Company to purchase any shares and may be terminated or amended by the Board at any time prior to its expiration date. As of September 14, 2021, the Company had repurchased approximately $163.8 million, or 6,522,823 shares, of its common stock through the Stock Buyback Program which includes 222,851 shares repurchased during the third quarter of 2021.


About Veritex Holdings, Inc.

Headquartered in Dallas, Texas, Veritex is a bank holding company that conducts banking activities through its wholly-owned subsidiary, Veritex Community Bank, with locations throughout the Dallas-Fort Worth metroplex and in the Houston metropolitan area. Veritex Community Bank is a Texas state chartered bank regulated by the Texas Department of Banking and the Board of Governors of the Federal Reserve System. For more information, visit www.veritexbank.com.


Forward Looking Statements

This press release contains certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on various facts and derived utilizing assumptions, current expectations, estimates and projections and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Forward-looking statements include, without limitation, statements relating to the expected payment date of Veritex’s quarterly cash dividend, the impact of certain changes in Veritex’s accounting policies, standards and interpretations, the effects of the COVID-19 pandemic and actions taken in response thereto, Veritex’s future financial performance, business and growth strategy, projected plans and objectives, as well as other projections based on macroeconomic and industry trends, which are inherently unreliable due to the multiple factors that impact broader economic and industry trends, and any such variations may be material. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing words. We refer you to the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Veritex’s Annual Report on Form 10-K for the year ended December 31, 2020 and any updates to those risk factors set forth in Veritex’s Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov. If one or more events related to these or other risks or uncertainties materialize, or if Veritex’s underlying assumptions prove to be incorrect, actual results may differ materially from what Veritex anticipates. Accordingly, you should not place undue reliance on any such forward-looking statements. Any forward-looking statement speaks only as of the date on which it is made. Veritex does not undertake any obligation, and specifically declines any obligation, to update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise, except as required by law. All forward-looking statements, expressed or implied, included in this press release are expressly qualified in their entirety by this cautionary statement. This cautionary statement should also be considered in connection with any subsequent written or oral forward-looking statements that Veritex or persons acting on Veritex’s behalf may issue.

Source: Veritex Holdings, Inc.



Investor Relations:
[email protected]

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Acuity Brands To Announce Fiscal 2021 Fourth Quarter Results on October 6, 2021

Atlanta, Sept. 15, 2021 (GLOBE NEWSWIRE) — Acuity Brands, Inc. (NYSE: AYI) (“Company”)  today announced that the Company is planning to release its fiscal 2021 fourth-quarter earnings results on Wednesday, October 6, 2021 at 6:00 a.m. (EDT) to be followed by a conference call at 8:00 a.m. (EDT).  Neil M. Ashe, Chairman, President and Chief Executive Officer of Acuity Brands, will lead the call.  

The conference call and earnings release can be accessed via the Investor Relations section of the Company’s website at investors.acuitybrands.com. The online replay will remain available for a limited time following the call. A replay of the call will also be posted to the Investor Relations site within two hours of the completion of the conference call and will be archived on the site.  

To learn more about Acuity Brands, please visit the company’s website. Acuity Brands uses its website as a channel of distribution for material company information. Financial and other material information regarding Acuity Brands is routinely posted on the company’s website and is readily accessible. 

About Acuity Brands

Acuity Brands, Inc. (NYSE: AYI) is a market-leading industrial technology company. Through its two business segments, Acuity Brands Lighting and Lighting Controls (ABL) and the Intelligent Spaces Group (ISG) the Company designs, manufactures, and brings to market products and services that make the world more brilliant, productive, and connected. Acuity Brands achieves growth through the development of innovative new products and services, including building management systems, lighting, lighting controls, and location-aware applications. 

Acuity Brands achieves customer-focused efficiencies that allow the Company to increase market share and deliver superior returns. The Company looks to aggressively deploy capital to grow the business and to enter attractive new verticals. 

Acuity Brands is based in Atlanta, Georgia, with operations across North America, Europe, and Asia. The Company is powered by approximately 12,000 dedicated and talented associates. Visit us at www.acuitybrands.com. 

# # #

Investor Contact:

Charlotte McLaughlin
Vice President, Investor Relations
(404) 853-1456
[email protected]



Posted on

InterDigital Issues Guidance for Third Quarter 2021

WILMINGTON, Del., Sept. 15, 2021 (GLOBE NEWSWIRE) — InterDigital, Inc. (NASDAQ:IDCC), a mobile and video technology research and development company, today provided guidance for third quarter 2021. 

The company expects third quarter 2021 total revenue to be between $119 million and $121 million, including approximately $89 million to $91 million of recurring revenue. The increase from second quarter 2021 is driven by both an expected $15 million of recurring revenue and $30 million of non-recurring revenue from a fixed price license agreement signed during third quarter 2021.

This revenue guidance does not include the potential impact of any new patent license, technology solutions or patent sale agreements that may be signed, or any arbitration or dispute resolutions that may occur, during the balance of third quarter 2021.

In addition, the company expects third quarter operating expenses to be in the range of $97 million to $105 million, driven by one-time expenses of approximately $18 million to $23 million associated with a previously announced restructuring and adjustments to compensation accruals.

About InterDigital

®

InterDigital develops mobile and video technologies that are at the core of devices, networks, and services worldwide. We solve many of the industry’s most critical and complex technical challenges, inventing solutions for more efficient broadband networks, better video delivery, and richer multimedia experiences years ahead of market deployment. InterDigital has licenses and strategic relationships with many of the world’s leading technology companies. Founded in 1972, InterDigital is listed on NASDAQ.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements include information regarding the company’s current expectations with respect to third quarter 2021 revenue. Words such as “expects,” “projects,” “forecasts,” “anticipates,” and variations of such words or similar expressions are intended to identify such forward-looking statements. 

Forward-looking statements are subject to risks and uncertainties. Actual outcomes could differ materially from those expressed in or anticipated by such forward-looking statements due to a variety of factors, including, but not limited to: (i) the outcome of discussions with the works council in France; (ii) the entry into additional patent license, patent sales or technology solutions agreements; (iii) the accuracy of market sales projections of the company’s licensees or our estimates of sales by our per-unit licensees; (iv) delays in payments from our licensees; (v) amounts of royalties payable following routine audits, if any, and the timely receipt of such amounts; (vi) the timing, expenses, and outcome of the company’s litigation and arbitration proceedings and the timely receipt of any related awards; (vii) new developments in the company’s litigation or arbitration proceedings; and (viii) the potential effects that the ongoing COVID-19 pandemic could have on our financial position, results of operations and cash flows. We undertake no duty to update publicly any forward-looking statement, whether as a result of new information, future events or otherwise except as may be required by applicable law, regulation or other competent legal authority. 

InterDigital is a registered trademark of InterDigital, Inc.

For more information, visit: www.interdigital.com.

InterDigital Contact:

Email: [email protected]
+1 (302) 300-1857